Continuous Glucose Monitoring Devices Pharmacy Policy

Transcription

1 Line of Business: All Line of Business Effective date: August 16, 2017 Revision date: August 16, 2017 Continuous Glucose Monitoring Devices Pharmacy Policy This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutic Subcommittee. Medicare Policy/Criteria: 1. Therapeutic continuous glucose monitoring (CGM) devices are considered medically necessary, when all of the following are met: a. Member has diabetes mellitus; b. Member has been using a home blood glucose monitor (BGM) and performing frequent BGM testing (at least 4 finger sticks per day); c. Member is insulin-treated with multiple daily injections (MDI) if insulin or a continuous subcutaneous insulin infusion (CSII) pump; d. Member s insulin treatment regimen requires frequent adjustment by the member on the basis of therapeutic CGM testing results e. Within 6 months prior to ordering the CGM, the treating practitioner has an inperson visit with the beneficiary to evaluate their diabetes control and determined that criteria (1-4) above are met; AND f. Every 6 months following the initial prescription of the CGM, the treating practitioner has an in-person visit with the beneficiary to assess adherence to their CGM regimen and diabetes treatment plan. Note: Diabetes education, training and support on CGM devices are highly recommended (e.g. sensor insertion, calibration, real-time data interpretation, etc.). 2. Request for gestational diabetes will be reviewed on a case-by-case basis 3. Long term use of continuous glucose monitors should not be used for other investigational indications that lack established clinical benefits including, but not limited to: nesidioblastosis (primary islet cell hypertrophy) and for blood glucose monitoring in nondiabetic patients following gastric bypass.

2 Medi-CAL Policy/Criteria: 1. Continuous glucose monitoring (CGM) devices are considered medically necessary, when all of the following are met: a. Members who are 18 years or older, or Members who are between 7-18 years old AND not covered by CCS. b. Member has type 1 diabetes mellitus, cystic-fibrosis related diabetes, or sequelae of a condition that requires chronic insulin use; c. Member requires insulin injections at least three times per day or uses an insulin pump; d. Member has documentation of at least one of the following: i. History of hypoglycemia (blood glucose <65mg/dl for children under 8 years old and <55mg/dl for all other ages) ii. History of hyperglycemia due to fear of hypoglycemia iii. Hypoglycemia unawareness e. Member has been seen by endocrine at least 2 times in the past 6 months to optimize glucose control and for diabetes education, training, and support on CGM devices; f. Member agrees to use the CGM most days g. Member demonstrates a high level of motivation to achieve tighter glucose control and competency to accurately use the CGM system and comply with recommended use h. Authorization for 6 months 2. Request for gestational diabetes will be reviewed on a case-by-case basis. 3. Long term use of continuous glucose monitors should not be used for other investigational indications that lack established clinical benefits including, but not limited to: nesidioblastosis (primary islet cell hypertrophy) and for blood glucose monitoring in non-diabetic patients following gastric bypass. Reauthorization Criteria: 1. Re-authorization for an additional 6 months is considered medically necessary when all of the following are met: a. Documentation of date the continuous glucose monitor was initiated b. Dates of the data download: a 2 week download of CGM data within the last 90 days is required; c. Medical documentation of: i. Average days per week CGM is used ii. Percent of time glucose is in target range or a statement in the medical record that member used CGM most days d. HbA1c level within the last 90 days. A level the same or lower than baseline is required, without an increase in hypoglycemia episodes, is required for reauthorization unless medical chart documentation contains reason for continuing medical necessity despite no clinical improvement

3 Centers for Medicare and Medicaid Services (CMS): National Coverage Determination (NCD) Local Coverage Determination (LCD) Local Coverage Article Home Blood Glucose Monitors (40.2) Glucose Monitor (L33822) Glucose Monitor- Policy Article (A52464) Applicable Codes: The Current Procedural Terminology (CPT) codes and/or Healthcare Common Procedure Coding System (HCPCS) codes listed in this policy are for reference purposes only. Listing of a service code in this policy does not imply that the service described by this code is a covered or non-covered health service. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. Other policies and coverage determination guidelines may apply. This list of codes may not be all inclusive. Below codes are current as of June 2017, for more details, please refer to the Medicare Coverage Database. Please note the following in accordance to the Medicare Local Coverage Determination (L33822): When a therapeutic CGM (code K0554) is covered, the related supply allowance (code K0553) is also covered. The supply allowance (code K0553) is billed as 1 unit of service per month. Only one unit of service of code K0553 may be billed to the DME MACs at a time. Billing more than 1 units of service per month of code K0553 will be denied as not reasonable and necessary. Please refer to the Coding Guidelines in the LCD-related Policy Article for additional information. HCPCS Code K0554 K0553 Group 1 Codes E0607 E0620 E2100 E2101 Group 2 Codes A4233 Description Receiver (Monitor), dedicated for use with therapeutic continuous glucose monitor system Supply allowance for therapeutic continuous glucose monitor, includes all supplies and accessories, 1 month supply = 1 unit of service Home blood glucose monitor Skin piercing device for collection of capillary blood, laser, each Blood glucose monitor with integrated voice synthesizer Blood glucose monitor with integrated lancing/blood sample Replacement battery, alkaline (other than J cell), for use with medically necessary home blood glucose monitor owned by patient, each

4 A4234 Replacement battery, alkaline, J cell, for use with medically necessary home blood glucose monitor owned by patient, each A4235 Replacement battery, lithium, for use with medically necessary home blood glucose monitor owned by patient, each A4236 Replacement battery, silver oxide, for use with medically necessary home blood glucose monitor owned by patient, each A4250 Urine test or reagent strips or tablets (100 tablets or strips) A4253 Blood glucose test or reagent strips for home blood glucose monitor, per 50 strips A4255 Platforms for home blood glucose monitor, 50 per box A4256 Normal, low and high calibrator solution/chips A4257 Replacement lens shield cartridge for use with laser skin piercing device, each A4258 Spring-powered device for lancet, each A4259 Lancets, per box of 100 A9275 Home glucose disposable monitor, includes test strips A9276 Sensor, invasive (e.g. subcutaneous), disposable for use with interstitial continuous glucose monitoring system, one unit = 1 day supply A9277 Transmitter, external, for use with interstitial continuous glucose monitoring system A9278 Receiver (monitor); external, for use with interstitial continuous glucose monitoring system Clinical Justification: Background: Managing optimal glycemic control while avoiding hypoglycemic and hyperglycemic excursions have been daily challenges for diabetic patients. Episodes of severe hypoglycemia and hyperglycemia can cause a tremendous, immediate impact mentally and physically. Maintenance of glycemic control near-normal limit has been shown to significantly decrease the development of long-term diabetic complications. CGM technology can provide guidance to treatment adjustments in order to optimize overall glycemic control by capturing continuous glucose fluctuation measurements that is not otherwise recorded by intermittent finger stick testing. Centers for Medicare and Medicaid Services On January 12, 2017, the Centers for Medicare & Medicaid Services (CMS) issued CMS Ruling 1682R addressing the benefit category for non-adjunctive CGM systems. CMS Ruling 1682R classified CGM system into therapeutic and non-therapeutic systems. Therapeutic CGM are defined as CGM used as a replacement for fingerstick blood glucose testing for diabetes treatment decision (i.e. non-adjunctive use). Non-therapeutic CGM are devices used as an adjunct to BGM testing (i.e. primary therapeutic decisions regarding diabetes treatment must be made with a standard home BGM, not the CGM).

5 For CGM products that are used in the home and approved by the FDA for use in place of a blood glucose monitor for making diabetes treatment decisions, these therapeutic CGMs are primarily and customarily used to serve a medical purpose because they are used by Medicare beneficiaries with diabetes who must measure their glucose level frequently and check trends in their glucose measurements for the purpose of adjusting their diet and insulin in the treatment of their diabetes. A receiver (or type of monitor) for a therapeutic CGM that has an expected life of at least 3 years and is the component performing the medically necessary function of accurately monitoring the trends of the patients blood glucose levels so that he or she can make necessary diabetes treatment decisions meets the 3-year-minimum lifetime requirement. A therapeutic CGM may be covered by Medicare when all of the following criteria are met: o The beneficiary has diabetes mellitus; and o The beneficiary has been using a home blood glucose monitor and performing frequent (four or more times a day) BGM testing; and o The beneficiary is inulin-treated with multiple daily injections of insulin or a continuous subcutaneous insulin infusion pump; and o The beneficiary s insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of therapeutic CGM testing results. American Diabetes Association- Standards of Medical Care in Diabetes 2017 When used properly, continuous glucose monitoring (CGM) in conjunction with intensive insulin regimens is a useful tool to lower A1C in selected adults (aged 25 years) with type 1 diabetes. Real-time CGM measures interstitial glucose (which correlates well with plasma glucose) and includes sophisticated alarms for hypo- and hyperglycemic excursions, but the U.S. Food and Drug administration (FDA) has not approved these devices as a sole agent to monitor glucose. CGMs require calibration with SMBG, with the latter still required for making acute treatment decisions. A 26-week randomized trial of 322 patients with type 1 diabetes showed that adults aged 25 years using intensive insulin therapy and CGM experienced a 0.5% reduction in A1C (from ~7.6% to 7.1%), compared with those using intensive insulin therapy with SMBG. A registry study of 17,317 participants confirmed that more frequent CGM use is associated with lower A1c, whereas another study showed that children with >70% sensor use missed fewer school days. A meta-analysis suggests that, compared with SMBG, CGM is associated with short-term A1C lowering of ~0.26%. This technology may be particularly useful in those with hypoglycemia unawareness and/or frequent hypoglycemic episodes, although studies have not shown consistent reductions in severe hypoglycemia. Due to variable adherence, optimal CGM use requires an assessment of individual readiness for the technology as well as initial and ongoing education and support. Additionally, providers need to provide robust diabetes education, training and support for optimal CGM implementation and ongoing use.

6 American Association of Clinical Endocrinologists and American College of Endocrinology Outpatient Glucose Monitoring Consensus Statement Adult Patients with T1DM People with T1DM experience much greater glycemic variability than those with T2DM. This variability is associated with a higher risk of hypoglycemic. GM has a role in the early detection of hypoglycemia prior to overt symptoms. These guidelines also recommend the use of CGM, particularly for patients with a history of severe hypoglycemia or hypoglycemia unawareness. Once again, the timing and frequency of monitoring must be individualized to meet specific patient needs. Pediatric Patients with T1DM As in the case of BGM, CGM is only as beneficial as the patient s desire and ability to use it. It is essential that all CGM users know the basic of sensor insertion, calibration, and real-time data interpretation. To maintain a high frequency of use, patients and their parents require in-depth training with reinforcement, including periodic follow-up with clinicians and diabetes educators. An international group of leading pediatric diabetologists issued a 2012 consensus statement regarding the use of CGM in children. They recommended that CGM be considered for regularly daily use in children and adolescents with T1DM who: o Are performing frequent BGM; o Have experienced severe hypoglycemic episodes; o Have hypoglycemic unawareness, especially in young children; o Have nocturnal hypoglycemia; o Have wide glucose excursions, regardless of A1C; o Having suboptimal glycemic control, with A1C exceeding the target range; o Have A1C levels <7% and wish to maintain target glycemic control while limiting hypoglycemia risk. Accordingly, CGM is potentially applicable and desirable in most children with diabetes. Recent enhancement has made it possible for parents and others to monitor glucose levels continuously via smartphones, wrist watches, and computers. Use of CGM in patients with T2DM There are limited data on the use of real-time CGM in patients with T2DM, either masked for retrospective analysis or unmasked for real-time use. Additional randomized trials of CGM will be helpful in the evaluation of the benefits of CGM in T2DM.

7 American Association of Clinical Endocrinologists and American College of Endocrinology Outpatient Glucose Monitoring Consensus Statement

8 The Journal of Clinical Endocrinology & Metabolism: Diabetes Technology Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline We recommend real-time continuous glucose monitoring (RT-CGM) devices for adult patients with T1DM who have A1C levels above target and who are willing and able to use these devices on a nearly daily basis. We recommend RT-CGM devices for adult patients with well-controlled T1DM who are willing and able to use these devices on a nearly daily basis. We suggest short-term, intermittent RT-CGM use in adult patients with T2DM (not on prandial insulin) who have A1C 7% and are willing and able to use the device. References: 1. Continuous Glucose Monitoring: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab, October 2011, 96(10): Standard of Medical Care in Diabetes American Diabetes Association. Diabetes Care. 2013;36 Suppl 1:S National Institute for Health and Care Excellence (NICE). Guidance on the use of patienteducation models for diabetes. Technology Appraisal Guidance 60. London, UK: NICE; Medtronic Minimed. Guardian RT Continuous Glucose Monitoring System. REF MMT Northridge, CA: Medtrnic Minimed; Pohar SL. Subcutaneous open-loop insulin delivery for type 1 diabetes: Paradigm (TM) realtime system. Issues in Emerging Health Technologies, Issue 105. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health (CADTH); Dexcom G4 Platinum Continuous Glucose Monitoring System, User s Guide. Dexcom, Inc., San Diego. Available at : Accessed December 18, Medicare Learning Network Matters. Number: SE0738 Revised August 28, An Overview of Medicare Covered Diabetes Supplies and Services. Available at: MLN/MLNMattersArticles/downloads/SE0738.pdf 8. National Coverage Determination (NCD) for Home Blood Glucose Monitors (40.2) 9. CMS Medicare Carrier LCDs. Glucose Monitors. Available at: Medical Review Criteria Guideline for Managing Care (Apollo) Continuous Glucose Monitoring Devices. 11. Handelsman, Y, Bloomgarden ZT, et al. Endocrine Practice Vol 21 (Supp 1) April Diabetes Care, The Journal of Clinical and Applied Research and Education. American Diabetes Association. January 2016, Vol 39 (Supp 1). Available at: Standards-of-Care.pdf. Accessed October 13, Bailey TS, Grunberger G, et al. Endocrine Practice, Vol 22 (No. 2). February Peters, AL, Ahmann AJ, et al. J Clin Endocrinol Metab. Doi: /jc Noridian Healthcare Solutions. Coding and Coverage- Therapeutic Continuous Glucose Monitors (CGM). Joint DME MAC Article. Available at:

9 Accessed April 5, State of California. Department of Health Care Services. N.L.: Continuous Glucose Monitoring (CGM) as a CCS/GHPP Program Benefit. March 6, 2017